1. Field of the Invention
The present invention relates to a device used for collection of uncontaminated urine samples from small children.
2. Description of the Prior Art
Infection of the urinary tract is a relatively common and potentially serious disease, especially in children. Urinary tract infection is diagnosed by demonstrating growth of bacteria in the urine. Crucial for the reliability of such analysis is that the enteric bacteria that normally colonize the skin of the uro genital area do not contaminate the urine sample. The most reliable ways to obtain an uncontaminated urine sample is by percutaneous bladder tap, urethral catheterization or by midstream specimen. These methods are, however, in many cases not suitable. Percutaneous bladder taps, as well as urethral catheterization, are proportionately traumatic procedures and midstream specimens are for practical reasons difficult to obtain, above all from small children since they usually are not able to produce a urine sample on demand. Ordinarily, a collecting bag attached to the genital area is therefore used. This allows the children to move around and does not imply any significant discomfort to them.
The collecting devices that are currently used are designed as a plastic bag. It has an opening on one side that is attached to the genital area with an adhesive material.
Examples of such devices can be found in patents GB 1051875, WO 0000111, SE 333792, U.S. Pat. No. 3,406,690, U.S. Pat. No. 3,523,537, and U.S. Pat. No. 3,200,415. Alternative designs are presented in U.S. Pat. No. 3,918,433 and GB 2163656. Common to the mentioned patents is, however, that they mainly focus on the attachment and collection functions of the device and that they do not address the risk of contamination. sufficiently. Other patents that address this problem can be found in U.S. Pat. No. 4,557,274, U.S. Pat. No. 4,492,258, and U.S. Pat. No. 3,881,465.
Using the above mentioned devices, a substantial part of the samples is rendered useless and has to be resampled since they have been contaminated with non-relevant bacteria. This leads to delay and difficulties in diagnosing and treatment, yielding over, as well as under, diagnosing the consequences, being apart from higher costs and ineffective use of medical care resources, unnecessary suffering for the patients and their parents.